WO2015022340A1 - Wundpflegeartikel aufweisend superabsorbierende fasern und superabsorbierende partikel - Google Patents
Wundpflegeartikel aufweisend superabsorbierende fasern und superabsorbierende partikel Download PDFInfo
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- WO2015022340A1 WO2015022340A1 PCT/EP2014/067282 EP2014067282W WO2015022340A1 WO 2015022340 A1 WO2015022340 A1 WO 2015022340A1 EP 2014067282 W EP2014067282 W EP 2014067282W WO 2015022340 A1 WO2015022340 A1 WO 2015022340A1
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- wound care
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Classifications
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- A61L15/00—Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
- A61L15/16—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons
- A61L15/22—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons containing macromolecular materials
- A61L15/28—Polysaccharides or their derivatives
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Definitions
- Wound care articles comprising superabsorbent fibers and superabsorbent particles
- the present invention relates to wound care articles comprising superabsorbent fibers, and superabsorbent particles.
- Superabsorbent polymers are known, for example, from EP 1507498 and have proven very useful in the treatment of chronic and highly exuding wounds.
- superabsorbent polymer particles are introduced into a cellulose matrix.
- the resulting relatively small proportion by weight of superabsorbent polymers may prove to be disadvantageous.
- the conventional wound dressings have a certain rigidity and low flexibility, which is disadvantageous for deep wounds, for example, because u.U. contact with the wound base can not always be guaranteed.
- This rigidity is not least due to the often very high density of such wound dressings, or their inner layers, conditional.
- the object of the present invention is to provide a wound care article which does not have these disadvantages.
- the invention relates to a wound care article having at least one flat layer of a fabric or a nonwoven comprising
- wound care article is intended in particular to designate a wound dressing, preferably a flat wound dressing or a wound care cloth.
- Said wound dressing contains a flat layer and can be designed to be both absorbent and non-absorbent or only insubstantially absorbent.
- wound care article may also be understood as an ensemble of various products placed in a given arrangement on the wound to be treated. This ensemble can form a physical unit by the various products are combined in a common shell or - if necessary, without a shell - are adhesively bonded together.
- the ensemble may also be in the form of a kit in which the various products are placed on the wound to be treated by means of a coil in the given arrangement.
- the term “fleece” refers to a textile fabric made of individual fibers which, unlike woven fabrics, knitted fabrics and knitted fabrics, is not made of yarns.Whats generally retain their structural integrity by adhesion of the individual fibers to one another.They are also called “nonwovens”. referred to, and produced, for example by Walken the fibers.
- the term “AMaid” refers to a special nonwoven fabric made from wood pulp and polyolefin fibers, in which superabsorbent polymers may be embedded.
- exudate refers to a fluid derived from the blood plasma via inflammatory processes.
- the exudate serves in a similar way the supply of the wound bed and the healing processes occurring therein. To cope with this multitude of functions, it contains a wide range of components, resulting in a specific weight that is slightly above that of water. This is also different from the transudate, which is derived from non-inflammatory processes and has a significantly lower specific gravity with a low cell and protein content. In addition to providing nutrients to the fibroblasts and epithelial cells, the nature of the exudate affects the various processes of wound healing, both temporally and spatially, due to its high content of growth factors and cytokines.
- the wound cleansing is also supported by the exudate. It contains various serine, cysteine and aspartate proteases as well as matrix metalloproteases, which in their activity severely regulate irreversibly damaged tissue and thus prepare the wound bed for the subsequent phases of healing. In general, such processes distinguish between physiological and pathological exudate.
- Components of the physiological exudate are in particular salts, glucose, cytokines and growth factors, plasma proteins, proteases (in particular matrix metalloproteases), granulocytes and macrophages.
- the wound care article according to the invention combines the properties of three different categories of wound care articles currently on the market: • It has a similarly high absorption capacity as wound care products, which has an airlaid mat comprising a cellulose fleece with embedded superabsorbent particles (example: product "sorbion sachet” from Sorbion GmbH & Co KG), is therefore also suitable for heavily exuding wounds Such wounds caused by deep-seated edema are suitable
- hydrofiber example: product "Aquacel” from ConvaTec
- Such a product having a wound care article according to the invention is commercially available, for example, under the name "sorbion soft".
- the superabsorbent fibers comprise a crosslinking polymer which comprises at least the monomer constituents
- Acrylic acid or acrylate (“AA), partially neutralized to the sodium salt (“AA-Na”),
- SAMM Special acrylate / methyl acrylate monomer
- SAMM acrylate / methyl acrylate monomer
- hexapropylene glycol monomethacrylate is particularly preferred.
- W, X, Y, and Z determine the proportions of the starting materials, while the values of U and V depend on the temperature of the manufacturing process.
- the quantitative composition may preferably be as follows (in moles):
- the said fibers may be formed with the other fibers mentioned to an airlaid.
- airlaid refers to a special nonwoven fabric in which superabsorbent polymers may be embedded.
- BBAL / LBAL Binder-Bonded Air-Laid / Latex-Bonded Air-Laid
- HBAL / XBAL Hydrogen-Bonded Air-Laid / X-Bonded Air-Laid
- SAP Superabsorbent particles
- C3H4O2 acrylic acid
- sodium acrylate sodium salt
- CXL core cross-linker
- the polymer becomes insoluble in water and, when water or aqueous salt solutions penetrate into the polymer particles, it swells up and tightens this network at the molecular level so that the water can no longer escape without assistance.
- the methylacrylic acid-based superabsorbents polyvinyl alcohol-maleic anhydride copolymers, polysaccharide-maleic anhydride copolymers, maleic acid derivatives, acrylamidopropanesulfonic acid copolymers, starch-acrylonitrile graft polymers, linanized starch derivatives, alkyl or hydroxyalkyl cellulose, carboxymethyl cellulose, starch-acrylic acid graft polymers , Vinyl acetate-acrylic acid ester copolymers, acrylonitrile or acrylamide copolymers.
- the superabsorbent particles may be present in powder or granular form in a particle size between 100 and about 1000 ⁇ .
- said superabsorbent polymers may also be hydrogel nanoparticles comprising hydroxy-terminated methacrylate monomers such as 2-hydroxyethyl methacrylate (HEMA) and / or 2-hydroxypropyl methacrylate (HPMA), e.g. marketed as Altrazeal act.
- HEMA 2-hydroxyethyl methacrylate
- HPMA 2-hydroxypropyl methacrylate
- the subject wound care article has a variety of advantages.
- the combination of different superabsorbent materials allows for rapid uptake of liquids without horizontally draining the liquid into the wide.
- a moist wound contact surface is generated which, under certain circumstances, has a cooling effect and produces a healing-promoting milieu, but at the same time prevents wet contact with the wound edges and associated wound edge lessening due to the absence of horizontal drainage.
- the wound care article according to the invention without the need for further treatment steps, already has a great softness and conformability and a pleasant feel, which the patient finds to be subjectively pleasant, but also offer great advantages objectively, since they counteract traumatization during dressing changes, allow an adaptation to the wound contour and at the same time reduce the pain sensation in the patient.
- the wound care article can also fill in fabric gaps or substance defects ("wound inlay"), in which case the wound care article does not lapping over the wound edge It can be ensured that the wound care article can make direct contact with the wound base and the exudate present there, thus ensuring a rapid uptake and discharge of the exudate.
- the wound care article according to the invention has strong antimicrobial properties, on the one hand by the property of the superabs . To bind proteins and bacteria are conditional, and on the other hand, due to their water-binding properties by which the bacteria for the activity necessary liquid is withdrawn. In addition, it ensures that the product retains its structural integrity even after ingestion of large quantities of exudate and can be removed as a whole from the wound.
- MMPs matrix metalloproteases
- ROS oxygen radicals
- ILlbeta IL6, IL8 and TNF alpha.
- the wound care article according to the invention is suitable for acute and post-interventional wounds, chronic wounds, such as, for example, diabetic wounds or pressure ulcers, tumor wounds, burns, mild to severe exuding wounds, and deep wounds, which possibly require defect replenishment.
- the sheet-like layer also has
- Said cellulose fibers may preferably be present as a so-called fluff pulp, and in addition to cushioning, they also have liquid-binding and structure-retaining properties.
- the bi-component fibers are preferably those fibers which facilitate thermoboding of the sheet-like layer. They therefore preferably contain a proportion of a thermoplastic polymer with a comparatively low melting point, for example of polyester, polypropylene or polyethylene, which melts when heated and thus acts as a hot melt adhesive (hot melt).
- the bi-component fibers contain, in addition to a thermoplastic polymer, a compound of at least one thermoplastic base polymer and at least one superabsorbent polymer (SAP).
- the melting point of the first-mentioned thermoplastic is preferably at least 20 ° C. higher than the melting point of the thermoplastic contained in the compound.
- Bi-component fibers absorb virtually no liquid, but have a high wicking effect on the other hand.
- Superabsorbent fibers take some time to pick up liquid, but then have a very high absorption capacity. In the initial phase, they have a very high wicking effect, which decreases rapidly with the beginning of the absorption process.
- the outer layers may be adjusted to have a low wicking effect, for example, to avoid wound edge maceration, while internal layers may be adjusted to have a high wicking effect to allow for large area distribution of the ingested liquid in the surface ,
- the terms “low wicking effect”, “medium-grade wicking effect” and “high wicking effect” are exemplarily quantified as so-called “vertical wicking height [cm / h]":
- the following table shows exemplary properties of a preferred sheet layer.
- the value ranges are to be understood here including the numerical value delimiting the value ranges.
- the planar position in the edge region is thinner, that is, conically tapering, for example, in cross-section at the edges. This ensures that there is a lesser order at the wound edges.
- the sheet-like layer is at least on one side of a thin nonwoven or underlaid.
- a thin nonwoven or underlaid may be, for example, a thin, water-permeable nonwoven made of polypropylene, polyethylene or polyester.
- this nonwoven can consist of a cellulose fleece.
- nonwoven fabrics mentioned to be treated in particular if they consist of a hydrophobic material, by a so-called finishing, which leads to improved wettability and thus facilitates the passage of liquid.
- this finish is u.U ,. affected by the subsequent calendering process.
- the most ideal possible symmetry of the layer structure is preferred. Is applied after several fiber layers in the manufacturing process If you work with an upper final nonwoven, there is a risk that the last-mentioned layer will not be penetrated by vertical fibers. This can cause the said upper final nonwoven to resist the liquid more than the lower nonwoven. For this reason, it may be provided that the top nonwoven, before it is applied, undergoes a shortened airlaid process in which fibers are blown onto the top nonwoven so as to cause perpendicular, nonwoven penetrating fibers to be introduced Facilitate the passage of fluid.
- the basis weight is preferably in the range between 2 to 50 g / m 2 , preferably 5 to 20 g / m 2 , particularly preferably 15 to 18 g / m 2 .
- Such a nonwoven improves the structural cohesion of the layer, in particular after the absorption of liquid.
- the superabsorbent fibers, the cellulose fibers and / or the bi-component fibers form a matrix. It is further preferred that the superabsorbent particles are embedded in this matrix.
- the wound care article according to the invention has a symmetrical layer structure.
- the symmetrical layer structure leads to a cross-sectionally symmetrical image of the wound care article. This is very advantageous for everyday clinical practice, because in this case the nursing staff can apply the wound care article to the wound without having to worry about the correct orientation.
- sanitary articles such as sanitary napkins, incontinence pads or diapers, which have a clear polarity, such that there is always an outwardly facing side and a side facing away from the body.
- the symmetrical layer structure places high demands on the manufacturing process. Wound care articles of the type mentioned are often produced in the so-called airlaid process.
- the fibers to be used in this case superabsorbent ing fibers and optionally bi-component fibers and cellulose fibers
- the fibers to be used are blown from above onto a web via a stream of air.
- several blower devices connected in series are used.
- the blowing process resides in the fact that the fibers applied by the second, third or further blowing device have the tendency to migrate downwards. This results in a redistribution of the fibers, which can affect the desired symmetry. Therefore, it may be advantageous for such a process to change the desired proportions of fibers in the individual blowing devices different from the actually required for a symmetry amounts so that the subsequent migration processes of the fibers are taken into account.
- the wound care article according to the invention may furthermore have at least one flat layer comprising cellulose fibers, foam, modified cellulose and / or alginates.
- foam refers to an open or closed-cell foam, preferably of polyurethane.
- Modified cellulose is preferably derivatives of cellulose, preferably nanocellulose, sulfonated and / or sulfoalkylated cellulose and derivatives thereof, preferably cellulose ethylsulfonates, carboxyalkylated cellulose, preferably carboxymethylcellulose, carboxyethylcellulose and / or carboxypropylcellulose, more complex cellulose derivatives, such as sulphoethylcarboxymethylcellulose, carboxymethylhydroxyethylcellulose, hydroxyethylcellulose propyl methyl cellulose, and amidated cellulose derivatives such as carboxymethyl cellulose amide or carboxypropyl cellulose amide.
- Carboxymethylcellulose in particular is in the form of sodium carboxymethylcellulose and is commercially available under the name "hydrofibre".
- the fibers are converted into a planar matrix. By absorbing fluid from the wound exudate, the fibers are gradually transformed into a gel pad that holds the fluid and does not release it again.
- the fibers are constructed so that the wound exudate is absorbed only in the vertical direction. This means that, as long as the capacity is sufficient, the exudate does not flow over the edge of the wound. On In this way, wound edge maceration can be effectively prevented.
- Chitins, chitosans and their derivatives should also be understood as cellulose derivatives in the present context. Alginates are extracted from brown algae and woven into a fibrous web.
- Alginates can absorb up to 20 times their own weight of liquid, while the wound exudate is stored in the cavities.
- the Ca 2+ ions contained in the alginate lattice are exchanged with the Na + ions from the exudate until the saturation level of Na ions in the alginate is reached. This leads to a swelling of the wound dressing and the conversion of the alginate fiber into a gel body by swelling of the fibers.
- the wound care article has a shell which consists at least partially of a liquid-permeable material.
- a shell has a varied function. It can u.a. prevent the wound care article from sticking to the wound, prevent backflow of exudate into the wound, have a hypoallergenic effect and prevent wound edge maceration.
- the sheath is preferably at least partially closed by a seam, for example an adhesive seam or an ultrasound seam, and may consist of a film or a film (for example made of PE) as well as a nonwoven (for example made of PP) or fleece
- the shell has pores which are on average smaller than the superabsorbent particles. In this way, trickling out of particles from the casing can be avoided. The latter can in particular hinder the sterilization process, namely when particles enter the area of the sealing barrier and possibly cause leaks there.
- the shell may also be coated or staggered with a heavy metal in elemental or ionic form, for example silver, zinc or copper.
- the sheath may also be coated with a material that binds to bacteria through hydrophobic interactions, such as dialkylcarbamoyl chlorides (DACC).
- DACC dialkylcarbamoyl chlorides
- the pore size also affects the flow rate of the exudate to be absorbed. This is especially true for more or less hydrophobic polymer materials.
- a suitable softening treatment it is generally possible to improve the wettability of the casing and thus also to ensure the flow rate even in the case of small pores.
- the pores or meshes of the shell are preferably 0.05 mm to 1.0 mm, preferably 0.20 mm to 0.50 mm in size. Furthermore, it can preferably be provided that the pores or meshes are delimited by the filament or fiber sections, which are approximately arc-shaped in section through the envelope and point outward with their arch apices.
- (i) in plan view of its flat side has a surface (Fl), which is in the non-wetted state by 3% to 75% smaller than the area (F2) of the interior provided by the shell, and / or
- the envelope has at least partially an elastic material.
- the elastic material may comprise, for example, lycra, elastane, polypropylene, rubber, latex or the like.
- the sheath consists at least partially of a three-dimensional wound distance grid or is covered or underlaid by this.
- Said wound distance grid is preferably a wound distance grid produced from a polyethylene film by blow molding, as described, for example, in EP2004116A1.
- it may be, for example, a silicone grid.
- Such a grid also has many functions. It may, depending on the configuration of the pores, perform a valve function and thus prevent the reflux of exudate (preferably in funnel or collar-shaped design of the pores). It can prevent the wound care article from sticking to the wound (preferably when using a silicone material). With a suitable arrangement, it can form abrasive properties and thus ablate the biofilms on the wound or prevent their formation (preferably in the case of funnel-shaped or collar-like configuration of the pores). It may also have hemostatic properties and may also be able to immobilize bacteria by static interactions (preferably when using a polyethylene material or a net positive charge material). Furthermore, the surface may be functionalized, for example with a silver or silicone coating. Preferably, it is further provided that the sheath consists at least partially of an impregnated or water-impermeable material or is covered or underlaid by this. This may be a colored optionally eye-catching designed laundry protection ("backsheet").
- backsheet a colored optionally eye-catching designed laundry protection
- the wound care article has a proportion of at least one elemental or ionic heavy metal.
- Heavy metals have a very finely divided form of bactericidal action, which due to the large reactive surface is due to the sufficient formation of soluble heavy metal ions.
- the primary dressing may be given an antibacterial effect, which may reduce complications in wounds susceptible to infection (bedsores, ulcer crural, burn wounds, etc.) and at the same time increase the residence time of the wound dressing.
- the at least one elemental or ionic heavy metal is selected from the group comprising copper, zinc and / or silver.
- the above-mentioned bactericidal properties apply in a special form for these three metals
- the flat layer or the shell is occupied or replaced by a cover at least on one side.
- said cover film has at least one of the following properties: Adhesive coating
- the cover extends beyond a periphery of the wound care article and attachable to the surrounding skin of the wound. In this way, a so-called border or Iceland dressing is realized.
- the casing itself has an adhesive coating on at least one side.
- the adhesive coating preferably comprises an acrylate adhesive, a silicone adhesive, a starch adhesive, a hydrocolloid adhesive and / or another suitable physiologically acceptable adhesive.
- the wound care article may further contain at least one member selected from the group consisting of
- Hyaluronic acid (preferred as a sheathing to superabsorbent polymers)
- the nonwoven according to the invention can be produced as follows: 1. Dry spinning
- 10 dtex superabsorbent fibers of a copolymer of the above composition are prepared by dry spinning from aqueous solution and cutting (staple length 6 mm), and then crosslinked at 200 ° C until ester bridges between the carboxylic acid and hydroxyl groups are formed.
- the superabsorbent fibers had an absorption of 50 g / g (measured by the Free Swell Absorbancy Test) and a retention under load of 35 g / g. 2.
- nonwovens For the production of wet-laid nonwovens, a Pulp Evaluation Apparatus from Mavis Manufacturing Company, London is used. All nonwovens were produced as 1.2 g dry weight webs. The required amount of dry cellulose (rayon XF grade) was dispersed at 5000 rpm in 2 liters of water with a high shear mixer. The
- Cellulose fiber had an absorbency of less than 10 g / g retention as measured by centrifuging 0.9 wt. Saline.
- the superabsorbent fiber was dispersed in 100 ml of water for a few seconds until swollen and then added to the dispersed cellulose fiber.
- the mixture was stirred with a spatula.
- the mixture was then added to a papermaking column and the nonwoven formed on a 25 mesh screen.
- the fibers were pressed and then dried at room temperature. This resulted in webs with the following properties.
- Exanple 3 20 0.96 0.24 12.88 10.56 1 shows a nonwoven according to the invention in a scanning electron micrograph.
- A denotes the superabsorbent fibers
- B the superabsorbent particles
- C a cushioning layer of cellulosic fibers and intervening air (“fluff pulp”) (D).
Priority Applications (8)
Application Number | Priority Date | Filing Date | Title |
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JP2016533912A JP6671755B2 (ja) | 2013-08-12 | 2014-08-12 | 超吸収性繊維及び超吸収性粒子を有する創傷ケア用品 |
MX2016001565A MX370332B (es) | 2013-08-12 | 2014-08-12 | Articulo para el cuidado de heridas que presenta fibras superabsorbentes y particulas superabsorbentes. |
AU2014307890A AU2014307890B2 (en) | 2013-08-12 | 2014-08-12 | Wound care article having super-absorbent fibers and super-absorbent particles |
EP14750375.9A EP3033116B1 (de) | 2013-08-12 | 2014-08-12 | Wundpflegeartikel aufweisend superabsorbierende fasern und superabsorbierende partikel |
BR112016002821-0A BR112016002821B1 (pt) | 2013-08-12 | 2014-08-12 | artigo para tratamento de feridas com fibras superabsorventes e partículas superabsorventes |
CN201480056100.4A CN105813660B (zh) | 2013-08-12 | 2014-08-12 | 具有超吸收性纤维和超吸收性颗粒的伤口护理制品 |
CA2921174A CA2921174C (en) | 2013-08-12 | 2014-08-12 | Wound care article having superabsorbent fibers and superabsorbent particles |
US15/008,105 US10925773B2 (en) | 2013-08-12 | 2016-01-27 | Wound care article having super-absorbent fibers and super-absorbent particles |
Applications Claiming Priority (4)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
DE102013108734 | 2013-08-12 | ||
DE102013108734.5 | 2013-08-12 | ||
DE202013104893.3 | 2013-10-31 | ||
DE202013104893.3U DE202013104893U1 (de) | 2013-10-31 | 2013-10-31 | Wundpflegeartikel aufweisend Superabsorbierende Fasern und Superabsorbierende Partikel |
Related Child Applications (1)
Application Number | Title | Priority Date | Filing Date |
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US15/008,105 Continuation US10925773B2 (en) | 2013-08-12 | 2016-01-27 | Wound care article having super-absorbent fibers and super-absorbent particles |
Publications (1)
Publication Number | Publication Date |
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WO2015022340A1 true WO2015022340A1 (de) | 2015-02-19 |
Family
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PCT/EP2014/067282 WO2015022340A1 (de) | 2013-08-12 | 2014-08-12 | Wundpflegeartikel aufweisend superabsorbierende fasern und superabsorbierende partikel |
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US (1) | US10925773B2 (es) |
EP (1) | EP3033116B1 (es) |
JP (1) | JP6671755B2 (es) |
CN (1) | CN105813660B (es) |
AU (1) | AU2014307890B2 (es) |
BR (1) | BR112016002821B1 (es) |
CA (1) | CA2921174C (es) |
MX (1) | MX370332B (es) |
WO (1) | WO2015022340A1 (es) |
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CA2921174A1 (en) | 2015-02-19 |
EP3033116A1 (de) | 2016-06-22 |
US10925773B2 (en) | 2021-02-23 |
BR112016002821A2 (pt) | 2017-08-01 |
JP6671755B2 (ja) | 2020-03-25 |
MX370332B (es) | 2019-12-10 |
AU2014307890B2 (en) | 2018-04-19 |
CN105813660A (zh) | 2016-07-27 |
CA2921174C (en) | 2021-03-23 |
CN105813660B (zh) | 2023-06-23 |
BR112016002821B1 (pt) | 2020-10-27 |
AU2014307890A1 (en) | 2016-03-03 |
US20160270966A1 (en) | 2016-09-22 |
EP3033116B1 (de) | 2021-04-07 |
MX2016001565A (es) | 2016-09-07 |
JP2016527065A (ja) | 2016-09-08 |
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